Quality Manual ISO 9001: Un-Controlled Copy
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1 Quality Manual ISO 9001: 2008 Un-Controlled Copy
2 This document is approved for use Copy Holder Copy Number 1 Leigh Holt a Director (hereafter referred to as the Management Representative) Distribution Copy No: Copy Number 1 Copy Number 2 Copy Number 3 Copy Holder etc.design Ltd Quality System Certifications Limited (Certification Copy - Uncontrolled) Copy Number 4 1 SCOPE 1.1 General This manual specifies the requirements for the Quality Management System (QMS) where etc.design Ltd: a) Demonstrates the ability to provide consistent services that meets their Clients and applicable regulatory requirements. b) Addresses Client satisfaction through the effective application of the quality system, including processes for continual improvement and the prevention of nonconformity. etc.design Ltd Scope The Provision of Architecture and Design Services. 1.2 Applications and Exclusions Validation of processes for production and service provision The Company provides no processes or services that come under this requirement of the Standard. Certificate Number: 3189 Document QM 01 Effective Date: Page 1 of 21 Issue: 3
3 Manual Contents Reference Title Page QM 01 Copy Holder 1 Distribution 1 SCOPE 1 QM 02 Manual Contents 2 Correspondence between and Procedures 3-4 QM 03 Amendments 5 Table of Amendments 6 QM 04 Practice Profile 7 QM 05 Process approach 8 PROCESS DIAGRAM 9 QM 06 Quality Policy 10 QM 07 Organisation 11 Normative References 11 Terms and Definitions 12 QM 08 Quality Management System 13 Management Responsibility 14 Resource Management 16 Service Realisation 17 Measurement, analysis and improvement 20 Document QM 02 Effective Date: Page 2 of 21 Issue: 3
4 Correspondence between and Procedures Scope 1 Standard General 1.1 Standard Application 1.2 Standard Normative reference 2 ISO 9000 Terms and definitions 3 Standard Quality management system 4 Title only Quality Management System references General requirements 4.1 Quality Manual, PM 01 Documentation requirements 4.2 Title only General documentation Quality Manual, PM 01 Quality manual documentation Quality Manual, PM 00, PM 01 Control of documents QM 04, PM 01 Control of records PM 01 Management responsibility 5 Title only Management commitment 5.1 QM 06, QM 07, PM 02 Client focus 5.2 QM 08, PM 02 Quality policy 5.3 QM 06 Planning 5.4 Title only Quality objectives QM 06 Quality management system planning Quality Manual & Procedures Manual Responsibility, authority and communication 5.5 QM 07, PM 02 Responsibility and authority QM 07, QM 08, PM 02 Management representative QM 07 Internal communication QM 07 Management review 5.6 PM 02 General PM 02 Review input PM 02 Review output PM 02 Resource management 6 Title only Provision of resources 6.1 PM 03 Human resources 6.2 Title only General PM 03 Competence, training and awareness PM 03 Infrastructure 6.3 PM 03 Work environment 6.4 PM 03 Document QM 02 Effective Date: Page 3 of 21 Issue: 3
5 Product realization 7 Title only Planning of product realization 7.1 QM 07 Client-related processes 7.2 Title only Determination of requirements related to the product PM 04 Review of requirements related to the product PM 04 Client communication PM 04 Design and development 7.3 Title only Design and development planning PM 04 Design and development inputs PM 04 Design and development outputs PM 04 Design and development review PM 04 Design and development verification PM 04 Design and development validation PM 04 Control of design and development changes PM 04 Purchasing 7.4 Title only Purchasing process PM 04 Purchasing information PM 04 Verification of purchased product PM 04 Production and service provision 7.5 Title only Control of production and service provision PM 04 Validation of processes for production and service provision Excluded Identification and traceability PM 04 Client property PM 04 Preservation of product PM 04 Control of monitoring and measuring equipment 7.6 PM 04 Measurement, analysis and improvement 8 Title only General 8.1 QM 07 Monitoring and measurement 8.2 Title only Client satisfaction PM 05 Internal audit PM 05 Monitoring and measurement of processes PM 05 Monitoring and measurement of product PM 05 Control of nonconforming product 8.3 PM 05 Analysis of data 8.4 PM 05 Improvement 8.5 Title only Continual improvement PM 05 Corrective action PM 05 Preventive action PM 05 Quality Management System references Document QM 02 Effective Date: Page 4 of 21 Issue: 3
6 Amendments All CONTROLLED copies of this Quality Manual are kept under strict control to prevent the System from becoming unreliable. The following procedures ensure that the system remains current and valid. 1.0 All CONTROLLED copies of the manual are clearly numbered and the Holder recorded on Document No QM 01, page 1 of 21, of the Quality Manual. 1.1 Each section in the manual is identified with a QM reference and each page in the manual is consecutively numbered. 1.2 The Management Representative or a nominee is responsible for all revisions being recorded in the Master Copy of the Quality Manual and in all other CONTROLLED copies that are held by the Practice. 1.3 Changes can be suggested by any member of staff but must receive the approval of the Management Representative before being entered into the Manual. 1.4 Upon approval of an amendment, the Management Representative or a nominee making it makes the relevant changes to the page(s), reprints it and replaces it in all CONTROLLED copies of the manual. 1.5 All changes are recorded on the Table of Amendments (QM 03 page 6 of 21) and appropriate pages in the Manual are changed. 1.6 Copies of the Quality Manual which are requested by, or sent to, third parties are clearly marked UNCONTROLLED and are not subject to updates. 1.7 NOTE: sections 1.4 & 1.5 refer to hardcopy control. If softcopy is employed as the Master Copy, the Management Representative controls the manual through password protection on the server and only allows the manual to be accessed as a READ ONLY DOCUMENT. The record of changes is maintained electronically on the system. Document QM 03 Effective Date: Page 5 of 21 Issue: 3
7 Document QM Table of Amendments Quality Manual Page Number Issue Date Description of Change Authorisation Whole Manual All Change to update manual to QM Updated organisation chart, removing Jennifer Mansell QM Updated the Organisation Chart. Change in personnel and Admin support LBH LBH NOTE 1: this table applies to hardcopy amendment records, if softcopy is used records of change and control are maintained on the system, as well as where required in Management Review Minutes. NOTE 2: an unlimited number of changes are permitted to the Table of Amendments without the need to up-issue it (i.e. it remains at issue level 1 unless its layout is changed) the original page is replaced when it is full and the previous page is retained for reference purposes. Document QM 03 Effective Date: Page 6 of 21 Issue: 3
8 Practice Profile etc.design Ltd is fully committed to providing the best possible professional service throughout all stages of the design and construction processes. In every case it offers a high degree of expertise and a competitive fee structure. The Practice has a strong commitment to a Continuing Professional Development policy, with all personnel involved, in order to continue to develop their Professional knowledge and technical skills. From its founding the Practice has built for itself a reputation for QUALITY, RELIABILITY and SERVICE which other practices strive to match. The Practice prides itself on a professional and friendly approach to its Clients. The objectives of the Practice are to: meet the requirements (Clients, regulatory bodies etc) for services supplied; meet planned schedules; increase business by no less than 5% over the next 12 months; employ and train sufficient personnel to meet business demands; maintain an effective management and quality system in the form of an ISO 9001:2008 Quality Management System; satisfy and enlarge its Client base and through this to enhance its long term profitability by supplying its high quality services, which conform to the specified requirements of its Client. Document QM 04 Effective Date: Page 7 of 21 Issue: 3
9 Process approach promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system to enhance Client satisfaction by meeting Client requirements. For etc.design Ltd to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next. The application of a system of processes, together with the identification and interactions of these processes and their management, can be referred to as the process approach. When used within a quality management system the process approach emphasises the importance of: a) understanding and meeting requirements, b) the need to consider processes in terms of added value, c) obtaining results of process performance and effectiveness, and d) continual improvement of processes based on objective measurement. The model of etc.design Ltd s process-based quality management system illustrating the process linkages of the Company is on page 9 of 21 in this manual. This shows the importance of the Client in defining requirements as inputs into the process and the need to monitor and evaluate Client satisfaction as the measure perception of whether etc.design Ltd has met the requirements. NOTE: the procedure known as Plan-Do-Check-Act (PDCA) can be applied to all processes. PDCA can be briefly described as follows. Plan: establish the objectives and processes necessary to deliver results in accordance with Client requirements and the Company's policies. Do: implement the processes. Check: monitor and measure processes and product against policies, objectives and requirements for the product/service and report the results. Act: take actions to continually improve process performance. Document QM 05 Effective Date: Page 8 of 21 Issue: 3
10 PROCESS DIAGRAM Client Sales & Marketing Practice Management Planning Policy and Objectives Regulations and Standards Main work process (Summary) CCl lli iiee nnt t ee nnqquui iir ryy/ //oor rddee r PPl llaa nn ww oor rkk //ggaai / iinn ppl llaa nnnni iinngg aa ppppr roovv aa llss l //ppuur / rcc hhaa ssee ss ee rvv r iiccee i ss (aass ( ree r qquui iir ree dd) ) DDee ss iiggnn i ree r qquui iir reemee nnt tss CCl lli iiee nnt t AAppppr roovv aal ll Resources and Training CPD Sub-contractors Where required CCaa rrr ryy oouut t aa nndd cc hhee cckk ww oor rkk SSi iit tee meeee tit iinnggss mi ii nnuut tee ss aa cc tit iioonnss ee tcc t Full details shown in Service Provision and other Procedures Performance Measurement Internal audit Nonconformance Corrective and Preventive action Collection and analysis of data Process performance Client Client Satisfaction Management Review Document QM 05 Effective Date: Page 9 of 21 Issue: 3
11 Quality Policy The Directors of etc.design Ltd recognise that the disciplines of quality, health and safety and environmental management are an integral part of its management function. The Practice views these as a primary responsibility and the key to good business practices. The Practice places particular emphasis on obtaining Client satisfaction by: Responding promptly and accurately to Client enquiries and contracts; A constant pursuit of quality, value and reliability in the services that the Practice supplies to its Client; Ensuring that its management and staff are fully trained to meet the requirements of the business and its Clients; Constantly striving to meet and where possible exceed its Client s expectations; Working closely with its Clients in seeking to establish the highest Quality standards; Adopting a forward-looking view on future business decisions which may have an impact on Quality; Training all members of staff in the needs and responsibilities of Quality Management. The Practice s Quality policy calls for continuous improvement in its Quality management activities and business is conducted according to the following principals: Complying with all applicable laws and regulations; Following a concept of continuous improvement and making best use of management resources in all Quality matters; Communicating Quality objectives and performance against these objectives throughout the Practice and to interested parties; Taking due care to ensure that activities are safe for employees, subcontractors and others who come into contact with our work; Providing complete Client satisfaction by delivering the highest quality services, on time, the first time, at a competitive price. The ability of etc.design Ltd to meet these objectives is measured through the internal audit processes that evaluate the effectiveness and efficiency of the Practice, as well as processes for continual improvement and for the detection and prevention of nonconformances. Client satisfaction is monitored and used as a basis for continual improvement. Signed:- Date:- 18/01/2010 Document QM 06 Effective Date: Page 10 of 21 Issue: 3
12 Organisation DIRECTORS Ian Tompkins Mike Cash Leigh Holt (Management Representative) TECHNICAL SUPPORT Robert Sargent - Senior Architectural Technologist Avinash Parmar - Architectural Assistant Helen Barker Architectural Assistant CONSULTANTS QS CDM Co-Ordinator Structural Engineer Mechanical and Electrical (and other consultants as required by a project) ADMINISTRATION SUPPORT Cathy Maltby - Office Administrator WORKING RELATIONSHIPS, AUTHORITY & RESPONSIBILITY The Directors define working relationships, authorities, and key responsibilities for all personnel. Working relationships are summarised in our Practice organisation chart above and individual reporting arrangements are documented in Personnel Files. Authorities on matters such as corporate governance, employment issues and service approval are vested in the Directors. Key responsibilities are established and maintained for each of the job positions indicated on the Practice chart. Due to the size and nature of our business, one person may hold more than one job position. Quality responsibilities may also be indicated in quality procedures and quality plans. All members of the Practice are responsible for complying with legal and regulatory requirements. Our quality policy statement is available to all Practice personnel who are expected to share a commitment to continuous quality improvement. 2 Normative References 2.1 Standards ISO 9000:2005 Quality Management Systems - Fundamentals and Vocabulary Quality Management Systems - Vocabulary ISO 9004:2000 Quality Management Systems - Guidelines for Performance Improvements Document QM 07 Effective Date: Page 11 of 21 Issue: 3
13 3 Terms and Definitions For the purposes of this document, the terms and definitions given in ISO 9000 apply. Throughout the text of the International Standard, wherever the term product occurs, it can also mean service. Top Management person or group of people who directs and controls an Organisation at the highest level (the Directors). The terms and definitions listed below are frequently used to describe our quality system. 1. Clause: specific quality management system requirement. 2. Client: Any organisation or person that receives services from etc.design Ltd. 3. Nonconformity: Problem - Situation where a requirement was not fulfilled. 4. Process: Set of interrelated or interacting activities, which transforms inputs (information, etc.) into outputs. 5. QMS: Quality Management System. 6. Supplier: Any organisation or person that provides a service to etc.design Ltd for inclusion in the service they supply to their Clients. 7. Document - information and its supporting medium. NOTE: The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or a combination thereof. ISO 9000: outsourced process is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party. NOTE: Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all client, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as a) the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements, b) the degree to which the control for the process is shared, c) the capability of achieving the necessary control through the application of 7.4 (purchasing). Document QM 07 Effective Date: Page 12 of 21 Issue: 3
14 4 Quality Management System 4.1 General The Directors of etc.design Ltd are committed to maintaining an effective Quality Management System (QMS). This manual has been prepared to satisfy the requirements of for etc.design Ltd. It covers the activities carried out at the site as defined in the Practice s address and for the scope stated in QM 01 page 1 of 21 of this manual. The Directors have determined the processes needed for the QMS and their application throughout the Company. Wherever possible, Quality controls have been integrated into existing systems (environment, health and safety) and cross-referenced for ease of interpretation. The effective implementation of the QMS is verified by regular inspections, reviews and audits that compare management Practice against the requirements of the written procedures on QMS standards. Corrective actions are taken where necessary and are subsequently reviewed for effectiveness. Note: control also apply to outsourced processes which are controlled through purchasing procedures. Structure The system documents are on 3 tiers or levels 1 This quality manual forms the top tier. It covers the following areas: contains a statement of our quality policy; sets out our objectives; generally outlines the system documentation; addresses the clause for management responsibility; refers to the procedures and other documents where the remaining applicable clauses are dealt with in greater detail. 2 The second tier largely consists of documented procedures. These specify controls on activities which may affect the quality of our services. In addition to these procedures, specific quality plans may be developed - as necessary - for an individual contract, service, or project. 3 The third tier includes detailed drawings, project files, forms, reports and records etc. The use of these documents may be referred to in procedures. Document QM 08 Effective Date: Page 13 of 21 Issue: 3
15 4.2 Documentation The Practice s Quality Policy states its objectives and this forms part of its Quality Manual, which is available to all Practice personnel. Its QMS has been developed taking into account its size, type, complexity of its business and the competence of its personnel. The Company s procedures cover all parts of the standard applicable to its scope of activities and justified exclusions. Documented procedures ensure that all relevant quality documentation is controlled and adequate and is reviewed, updated and approved as necessary. The status of the documents is identified and they are legible and retrievable and located where required within the Company. Where documents originate from outside the Company, they are identified and their distribution controlled. Obsolete documents are clearly identified to prevent unintended use. Records have been established, to provide evidence of conformity to requirements and of the effective operation of the QMS and they are controlled and maintained in such a way as to remain legible, readily identifiable and retrievable. Procedures are in place, which define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. 5 Management Responsibility 5.1 Commitment The Directors ensure that all members of staff are aware of the need to meet Client and regulatory requirements and that the necessary resources are available. The currency of quality policy and objectives is maintained by regular management review. 5.2 Client Focus Client needs and expectations are determined and fulfilled to meet their satisfaction. Due consideration is given to service, regulatory and legal requirements. 5.3 Policy The Directors have established, through the quality policy, the need to meet Client requirements and to continually improve its services. Quality objectives are reviewed for continuing suitability and communicated as appropriate throughout the Practice. Document QM 08 Effective Date: Page 14 of 21 Issue: 3
16 5.4 Planning The Directors have established at Management Review that all relevant functions and levels within the Practice have clear, measurable quality objectives that are consistent with the Practice s quality policy and service requirements. The setting of and measurement of quality objectives is carried out at Management Review under Item 2. NOTE: at such times new objectives may be set as well as progress upon achieving existing ones reported upon. Adequate resources are available and output is planned in a controlled manner, as is required by its QMS, being mindful of the process and the need for continual improvement. 5.5 Responsibility, authority and communication The Directors ensure that responsibility and authorities within the Company are defined in the Organisation chart and Job Description. All the Company s personnel understand the significance of meeting Client requirements Leigh Holt, a Director has been appointed as Management Representative and has the authority and responsibility to ensure that the QMS is established and maintained and to report on the performance of the system and any needs for improvement at Management Reviews Elements of the QMS have been defined and communicated wherever quality is affected. Communication between all levels and functions within the Company are set to ensure the effectiveness of the processes of the QMS. 5.6 Management Review The complete QMS is reviewed at planned intervals to ensure its continuing suitability, adequacy and effectiveness to evaluate the need for change and results of management review activities and subsequent improvement are recorded Review inputs must include, but are not limited to: results of audits; Client feedback; process and service delivery conformity; status of preventive and corrective actions; follow-up from previous management reviews; changes that could affect the QMS, and recommendation for improvement. Document QM 08 Effective Date: Page 15 of 21 Issue: 3
17 5.6.3 Central to the management review is its three main outputs: improvement of the effectiveness of the QMS and its processes; improvement of services related to Customer requirements, and resource needs. 6 Resource Management 6.1 Provision of Resources The Directors ensure that the necessary resources needed to implement and improve the QMS and to address Client satisfaction are available. 6.2 Human Resources Where personnel are assigned quality responsibilities, the Directors ensure that they are competent on the basis of applicable experience, skills, education and CPD training The Directors are responsible for the competence, training and awareness of Company personnel by: determining the necessary competence for personnel performing work affecting conformity to service requirements, where applicable, provide training or take other actions to achieve the necessary competence, evaluate the effectiveness of the actions taken, ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and maintain appropriate records of education, training, skills and experience. 6.3 Facilities The Directors provide and maintain premises that are suitable for the Practice s activities. In addition they are responsible for ensuring that adequately equipped workplaces with appropriate hardware, software and supporting services are also provided. 6.4 Work environment All aspects of the human and physical factors of the working environment that affect conformity of the services provided are identified and managed. Document QM 08 Effective Date: Page 16 of 21 Issue: 3
18 7 Service Realisation 7.1 Planning of realisation process The Practice s service delivery processes are planned and documented as defined in the QMS. Quality objectives, resources, processes and documentation needs are defined, as are acceptable criteria for verification and validation. Records are maintained, appropriate to the level of confidence required for the services supplied. 7.2 Client related processes The needs of the Client in respect of service delivery, availability, delivery, support etc are considered against the service requirements, as well as against regulatory and legal requirements that require determination and implementation A Director reviews Client s requirements and determines any additional provisions for each contract or project. Any changes to contracts or terms are resolved before proceeding and the Practice s ability to meet the defined requirements is confirmed Clients are kept informed on service information, enquiries, order changes or amendments and progress on any complaints received This information is used to assess the Practice s ability to meet Client needs. Contractual requirements are evaluated against current resources to ensure that the capability exists to fulfil the contract terms. 7.3 Design and/or development The design process and project administration are controlled in accordance with established procedures. These are based on the content of the RIBA Plan of Work stages which are briefly described below: Document QM 08 Effective Date: Page 17 of 21 Issue: 3
19 A. Appraisal Identification of Client s needs and objectives, business case and possible constraints on development. Preparation of feasibility studies and assessment of options to enable the Client to decide whether to proceed B. Developed Brief Development of initial statement of requirements into the Developed Brief by or on behalf of the Client confirming key requirements and constraints. Identificatio n of procurement method, procedures, organisational structure and range of consultants and others to be engaged for the project C. Concept Implementation of Developed Brief and preparation of additional data. Preparation of concept design including outline proposals for structural and building services systems, outline specifications and preliminary cost plan. Review of procurement route D. Design Development Development of concept design to include structural and building services systems, updated outline specifications and cost plan. Completion of final Brief. Application for detailed planning permission E. Technical Design Preparation of technical design(s) and specifications, sufficient to co-ordinate components and elements of the project and information for statutory standards. F. Production Information G. Tender Documentation F1 Preparation of detailed information for construction. Application for statutory approvals. F2 Preparation of further information for construction required under the building contract. Review of information provided by specialists Preparation and/or collation of tender documentation in sufficient detail to enable a tender or tenders to be obtained for the project. H. Tender Action Identification and evaluation of potential contractors and/or specialists for the project. Obtaining and appraising tenders; submission of recommendations to the client. J. Mobilisation Letting the building contract, appointing the contractor. Issuing of information to the contractor. Arranging site hand over to the contractor. K. Construction to Practical Completion L. Post Practical Completion Administration of the building contract to Practical Completion Provision to the contractor of further Information as and when reasonably required. Review of information provided by contractors and specialists L1 Administration of the building contract after Practical Completion and making final inspections. L2 Assisting building user during initial occupation period L3 Review of project performance in use The activities in italics may be moved to suit project requirements, i.e.: D Application for detailed planning approval; F1 Application for statutory approvals; and F2 Further information for construction. G+H Invitation and appraisal of tenders Document QM 08 Effective Date: Page 18 of 21 Issue: 3
20 7.4 Purchasing The Directors control the purchasing function to ensure that the purchased services conform to requirement. Suppliers are selected against defined criteria and are subject to planned review and evaluation. The results of evaluations and follow up actions are recorded Purchasing records are reviewed before release for the adequacy of information on service, procedures, processes, equipment and personnel The Practice verifies its purchased services and where verification takes place at the suppliers premises, details of the arrangements and the method of release are specified. 7.5 Service delivery operations The design and service delivery processes of the Practice are planned and documented as defined in the QMS. Quality objectives, resources, processes and documentation needs are defined, as are acceptable criteria for verification and validation. Records are maintained, appropriate to the level of confidence required for the process and the service The Practice provides no services for which it would be required to validate its processes for service delivery provision Where appropriate, the Practice identifies the services it provides throughout the delivery process and identifies its status with respect to checking and monitoring activities. Where traceability is required, the unique identification of the service provisions are controlled and recorded Client s property includes sites and intellectual property which may be supplied to the Practice. Procedures are in place, which ensure that they are identified, acceptable for the agreed use and that they are kept safe. Any change in the condition of these items is notified to the Client and recorded. In addition personal data is secured and handled under the Company s Data Protection Policy The Practice preserves the conformity of the services it provides from start to conclusion of their delivery. Document QM 08 Effective Date: Page 19 of 21 Issue: 3
21 7.6 Control of monitoring and measuring equipment Where the conformance of the service delivered is indicated by inspection and test measurements, it is essential that the equipment/software used on these tasks is accurate Where equipment is used for measurements it is commercially available (e.g. tape measures) and replaced as needed. 8 Measurement, analysis and improvement 8.1 Planning The requirements for measurement and monitoring have been determined along with the methods to use. 8.2 Measurement and monitoring Clear methods are established to audit Client satisfaction and any failures to meet Practice standards Suitably trained personnel conduct periodic independent internal audits on a planned basis. All aspects of internal audits are recorded and reviewed and corrective action is taken where necessary Processes affecting Client requirements are periodically reviewed to ensure that the intended purpose is being met Measuring and monitoring of the Practice s service delivery is designed to ensure the delivered service meets agreed specifications. 8.3 Control of nonconformity Documented procedures are in place to identify and isolate nonconforming services. Prior to returning to the process, any such services are corrected and re-checked. In the event of a problem (nonconformance) reaching a Client, appropriate corrective action is taken. Document QM 08 Effective Date: Page 20 of 21 Issue: 3
22 Where applicable, the Practice deals with nonconformances by one or more of the following ways: by taking action to eliminate the detected nonconformity; by authorising its use, release or acceptance under concession by a relevant authority and, where applicable, by the Client; by taking action to preclude its original intended use or application; by taking action appropriate to the effects, or potential effects, of the nonconformity when a nonconformance is detected after delivery or use has started. When a nonconformance is corrected it is subject to re-verification to demonstrate conformity to the requirements. 8.4 Analysis of data Data referring to service quality problems is collected and analysed, and where changes to the QMS offer improvements, these changes are introduced. Areas for attention are Client complaints, meeting Client needs, service delivery characteristics and, where applicable, supplier performance. 8.5 Improvements The QMS is operated in a way that ensures opportunities for continual improvement are identified, having regard to statements in its Quality Policy and Objectives, using audit results, data analysis, corrective and preventive action and Management Review as the mechanisms Appropriate action is taken to rectify faults and prevent their reoccurrence and the procedure is documented. Requirements for identifying faults and determining their cause with appropriate corrective action is covered and recorded and the results are reviewed The Practice identifies preventive actions to eliminate or minimise the recurrence of nonconformances and the results of such actions are recorded and reviewed for their effectiveness. END OF QUALITY MANUAL Document QM 08 Effective Date: Page 21 of 21 Issue: 3
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